FDA-Device2026-05-20Class IIPROCESSING DEFECT

Dexcom ONE+ iOS app recalled for delayed glucose alerts risk

OTHERNationwide distributionMedical devices

What this means

A software defect in the Dexcom ONE+ iOS app (versions 1.5.0 and 1.6.0) can delay glucose value notifications when the app runs in the background. When you open the app, glucose readings may display out of order or the app may incorrectly signal loss of connection. This delay could cause you to miss alerts for dangerously high or low blood sugar, or make treatment decisions based on outdated information.

Update your Dexcom ONE+ iOS app to the latest version available in the App Store.
If you cannot update immediately, keep the app running in the foreground when monitoring glucose levels.
Contact Dexcom if you experience delayed or missing glucose alerts.

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The agency's original wording

Hazard

A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.

Intended for

Adults

Illnesses reported

None reported

Sold states

SW12300 & SW13355 Dexcom G7 iOS and watchOS app versions 2.9.0 through 2.11.2: Worldwide - US Nationwide including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Austria, Australia, Belgium, Bahrain, Canada, Czech Republic, Germany, Denmark, Estonia, Finland, France, Hong Kong, Ireland, Israel, Iceland, Italy, Jordan, Japan, Kuwait, Luxembourg, Malta, Netherlands, Norway, New Zealand, Oman, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Slovenia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom. SW14245 Dexcom ONE iOS App versions 1.5.0 and 1.6.0 - Only International distribution to the countries of Andorra, Australia, Belgium, Bulgaria, Czech Republic, Estonia, France, Greece, Croatia, Ireland, Italy, Lithuania, Latvia, Malaysia, Monaco, Netherlands, New Zealand, Poland, Qatar, Romania, Saudi Arabia, Spain, Sweden, United Kingdom.

Affected count

70212

Manufactured in

6340 Sequence Dr, San Diego, CA, United States

Products

Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.5.0 and 1.6.0 Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring System

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2165-2026

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